跳至主要内容
临床试验/NCT05006313
NCT05006313撤回不适用

Intraoperative Fluorescence Angiography in Debridement of Open Fractures

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
20
试验地点
2
主要终点
Additional debridement following IFA use

研究概览

简要总结

The proposed research aims to be a pilot feasibility study to evaluate intraoperative fluorescence angiography (IFA) as an aid for acute debridement in orthopaedic trauma.

详细描述

The investigators will perform a prospective cohort study evaluating the utility of IFA in acute debridement of type II and type III open extremity fractures by testing the frequency that IFA leads to additional debridement of compromised tissue. The investigators will also identify the incidence of clinically important secondary outcomes for future evaluation in a multicenter randomized controlled trial. Secondary outcomes will include the occurrence of a secondary procedure for surgical debridement, the need for a soft tissue coverage procedure, and the incidence of post-operative wound complications. Additionally, the investigators will evaluate surgeon experience using IFA to understand ease of use and surgeon satisfaction.

At the conclusion of this study, the investigators will be able to understand how often IFA may assist surgeons perform successful debridement and potential advantages of use. IFA may improve debridement by identifying tissue that is not viable but difficult to assess by the current gold standard, clinical acumen, or by giving surgeons confidence that the debridement is adequate and that the wound may be safely closed. Ultimately, IFA may prove to reduce the need for further procedures and potentially reduce the post-operative infection rate.

Aim 1: Evaluate the frequency that IFA leads to the debridement of additional tissue during the same operative procedure for type II and type III open extremity fractures following an initial debridement using clinical measures of tissue viability.

Hypothesis: Adult patients (≥18 years old) undergoing surgical debridement of an upper or lower extremity type II or type III open fracture will have additional tissue debrided after use of IFA in at least 18% of cases, the frequency reported in plastic surgery literature.

A) Patients will undergo a standard initial debridement by the treating surgeon. When the surgeon feels the debridement is complete, IFA will be performed.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All adults ≥18 years old
  • Open type II or type III upper or lower extremity fracture to be treated at Vanderbilt University Medical Center with operative intervention by orthopaedic trauma or orthopaedic hand surgeons.

排除标准

  • Patients <18 years old
  • In extremis or requiring expedited surgical care outside of standard treatment
  • Allergy or medical contraindication to indocyanine green dye.

结局指标

主要结局

Additional debridement following IFA use

时间窗: Intraoperative

Yes/No

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jed Maslow

Assistant Professor of Orthopaedic Surgery

Vanderbilt University Medical Center

研究点 (2)

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